2018 Common Rule Update

Major Regulatory Changes

Exemptions
Categories have been updated, mostly to expand the type of research qualifying for exemption. New categories have been added.

Expedited Continuing Review
Continuing review is no longer required for minimal risk research, including research originally reviewed by the convened IRB that now qualifies for expedited categories 8 or 9.

Informed Consent
Consent forms are now required to include a “Key Elements” section and new elements of informed consent are required in some circumstances.

Single IRB of Record
Beginning January 20, 2020, most federally-funded multi-site/collaborative research projects occurring in the U.S. will be required to use a single IRB.

Minor Regulatory Changes

Human Subject Research
The definition of what qualifies as human subject research has been updated to include identifiable biospecimens and to specifically exclude particular types of non-research activities.

Waiver of Informed Consent
In order to approve a waiver of informed consent, in addition to previously existing waiver criteria, the IRB must now also determine: If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format.